Value of tofacitinib extended induction therapy in patients with moderate-to-severe ulcerative colitis: A real-world 52-week follow-up study.
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Tzouvala Maria, Zacharopoulou Eirini, Kalafateli Maria, Viazis Nikos, Psistakis Andreas, Theodoropoulou Angeliki, Drygiannakis Ioannis, Karmiris Konstantinos, Koutroubakis Ioannis E, Kevrekidou Polyxeni, Soufleris Kostas, Katsaros Marios, Giouleme Olga, Fousekis Fotios, Katsanos Konstantinos, Christodoulou Dimitrios, Gaki Aikaterini, Papathanasiou Evgenia, Bamias Giorgos, Zampeli Evanthia, Michopoulos Spyridon, Kyriakos Nikolaos, Veretanos Christos, Argyriou Konstantinos, Kapsoritakis Andreas, Tribonias George, Mantzaris Gerassimos J, Liatsos Christos
Аннотация
AIM: To assess predictors for clinical remission and drug persistence in patients with UC receiving the extended induction tofacitinib protocol.
METHODS: This was a real-world multicenter retrospective study in patients with moderate-to-severe UC. Patients received physician-directed extended induction tofacitinib treatment. We collected clinical and demographic data at baseline and data regarding clinical, laboratory, and endoscopic evaluations, therapeutic modifications, and adverse events at the 52-week follow-up. Possible predictors for clinical remission at week 52 was the primary endpoint. Differences between patients receiving 5 mg bid vs 10 mg bid at week 52 and identification of predictors for treatment persistence were secondary endpoints.
RESULTS: Thirty-seven consecutive patients from 11 medical centers were included [51.4% males with median age 39 (17-64) years]. Twenty-eight patients continued treatment until week 52 (75.7%) with 67.9% receiving 10 mg tofacitinib; all had prior history of biologic use. We observed that 57.1% of patients achieved clinical remission (66.7% in the 5 mg tofacitinib group and 52.6% in the 10 mg tofacitinib group, P = 0.483). De-escalation to 5 mg tofacitinib was attempted in 17 patients with a success rate of 52.9%. Prior biologic use was significantly more frequent in patients treated with 10 mg tofacitinib. Active smoking was significantly associated with treatment discontinuation at week 52. We identified eight adverse events, and only one led to treatment discontinuation.
CONCLUSION: Our results supported the extended induction strategy with tofacitinib in selected patients with UC. Patients with prior failure of advanced therapies particularly benefitted, highlighting the importance of personalized maintenance regimens.